注射用盐酸克林霉素细菌内毒素检查方法

Study on Determination of Bacterial Endotoxinin Clindamycin Hydrochloride for Injection

目的建立注射用盐酸克林霉素的细菌内毒素检查方法。方法按2005年版《中国药典(二部)》附录ⅪE进行试验并判定结果。结果供试品溶液质量浓度为3 g/L时,对细菌内毒素检查无干扰。结论注射用盐酸克林霉素用细菌内毒素检查法代替热原检查法可行。

Objective To set up the bacterial endotoxin determination method of Clindamycin Hydrochloride for Injection.Methods The experiment was carried on and the result was judged according to the Appendix ⅪE of Chinese Pharmacopoeia（2005,Vol.Ⅱ）.Results The concentration of 3 g/L for Clindamycin Hydrochloride for Injection had no interference to bacterial endotoxin test.Conclusion The established method of endotoxin test is feasible to Clindamycin Hydrochloride for Injection.